Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction： a Muti-center, Open-label, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 5
- 主要终点
- myocardial salvage index
研究概览
简要总结
This is a multi-center, prospective, randomized, controlled study. The patients with STEMI who were to undergo PPCI were divided into PCSK9 inhibitor group (n=80) and conventional treatment group (n=80) using the interactive web response system (IWRS), at a 1:1 ratio. In the PCSK9 inhibitor group, a dose of PCSK9 inhibitor (alirocumab) was injected subcutaneously immediately after PPCI and was administered every two weeks thereafter for 3 months; the control group received conventional treatment. Cardiac Magnetic Resonance Imaging (MRI) were used to measure myocardial salvage index at 1 week after operation as primary endpoints. Eject fraction at 6 months after operation will also be measured by MRI as secondary endpoints. Serum TnI/T，CKMB levels were detected q8h for three times and and LDL-C levels were detected at 1 month, 3 months and 6 months after operation. Blood inflammation indicators were detected before and 1 week after the operation, and 6 months after the operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age is greater than 18 years old and less than or equal to 80 years old.
- •Patients who are clinically diagnosed with STEMI onset within 24 hours and who are planning to undergo PPCI .
- •Signed informed consent.
排除标准
- •Patients who are allergic to PCSK9 inhibitors.
- •Multivessel disease planned for selective intervention within half a year.
- •Patients who have previously undergone revascularization.
- •Pregnant women or women who plan to become pregnant in the next 2 years.
- •Patients whose life expectancy is less than 1 year.
- •Severe liver or kidney dysfunction (ALT>5 times ULA, eGFR<15ml/min/1.73m2)
- •Known active malignant tumor diseases.
- •Patients considered by the investigator to be unsuitable to participate in this study.
研究组 & 干预措施
Early PCSK9 inhibitor treatment group
干预措施: alirocumab (Drug)
conventional treatment group
干预措施: conventional treatment (Other)
结局指标
主要结局
myocardial salvage index
时间窗: 1 week after operation
measured by Magnetic Resonance Imaging (MRI)
次要结局
- Eject fraction(at 6 months after operation)
研究者
Hou Lei
Principal Investigator
Shanghai Tong Ren Hospital